Ignite Creation Date:
2025-12-24 @ 9:22 PM
Ignite Modification Date:
2025-12-25 @ 7:09 PM
Study NCT ID:
NCT04713904
Status:
COMPLETED
Last Update Posted:
2021-04-15
First Post:
2021-01-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bioavailability of Clormadinone/Ethinyl Estradiol Tablets 2 mg/0.02 mg With Regards to Reference Product
Sponsor:
Laboratorios Andromaco S.A.
Organization:
Study Overview
Official Title:
Bioavailability of Formulation Clormadinone/Ethinyl Estradiol Coated Tablets 2 mg/0.02 mg With Regards to the Marketed Reference Product
Status:
COMPLETED
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study will be performed at a single site with 38 subjects. Participantswill take 2 tablets of the test product and reference product in 2 periods and 2 sequences (either test after reference or reference after test). There will be a washout of at least 14 days between each study period.
Detailed Description:
The primary objective of the study is to investigate the relative bioavailability of Clornadinone and Ethinyl estradiol of 2 tablet formulations with Clormadinone 2 mg and Ethinyl estradiol 0.02 mg and to demonstrate bioequivalence of both formulations in terms of rate and extent of absorption:
* Test Product: Product manufactured by Laboratorios Andrómaco S.A.
* Reference Product: Evafem 20 \[Trademark\], product of Grünenthal. The 90% confidence intervals for the intra-subject coefficient of variation (Test versus Reference Product) for the main pharmacokinetic parameters area under the plasma concentration-time curve from time zero to time t (AUC0-t) and from time zero to 72 hours (AUC0-72), and maximum plasma concentration (Cmax) for total Clormadinone and Ethinyl estradiol will be determined.
Participants will be confined in the study site for approximately 36 hours during each study period (for 12 hours pre-dosing and for 24 hours post dosing) during which pharmacokinetic (PK) blood samples will be obtained. 16 blood samples will be taken up to 24 hours after the administration in each period. Participants will return to the site to provide additional blood samples at 48 h, and 72 h postdose. The washout period between the two study periods will be at least 14 days. The samples from each participant will be analyzed with 2 methods of high performance liquid chromatography-tandem mass spectrometry bioanalytical assays to quantify total Clormadinone and Ethinyl estradiol in plasma.
The safety objective is to evaluate the tolerability of both formulations in women by collecting adverse events.
* Test Product: Product manufactured by Laboratorios Andrómaco S.A.
* Reference Product: Evafem 20 \[Trademark\], product of Grünenthal. The 90% confidence intervals for the intra-subject coefficient of variation (Test versus Reference Product) for the main pharmacokinetic parameters area under the plasma concentration-time curve from time zero to time t (AUC0-t) and from time zero to 72 hours (AUC0-72), and maximum plasma concentration (Cmax) for total Clormadinone and Ethinyl estradiol will be determined.
Participants will be confined in the study site for approximately 36 hours during each study period (for 12 hours pre-dosing and for 24 hours post dosing) during which pharmacokinetic (PK) blood samples will be obtained. 16 blood samples will be taken up to 24 hours after the administration in each period. Participants will return to the site to provide additional blood samples at 48 h, and 72 h postdose. The washout period between the two study periods will be at least 14 days. The samples from each participant will be analyzed with 2 methods of high performance liquid chromatography-tandem mass spectrometry bioanalytical assays to quantify total Clormadinone and Ethinyl estradiol in plasma.
The safety objective is to evaluate the tolerability of both formulations in women by collecting adverse events.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: